BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2253893 · Received September 12, 2011

    Report

    Report Number
    3006556115-2011-00443
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING PAIN, DIZZINESS, AND HEADACHE WITH DEVICE USE. TESTING SHOWED THAT THE DEVICE IS FUNCTIONING. REVISION SURGERY IS BEING DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC. AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention